Clinical Affairs Data Specialist

Grifols
Grifols
Sant cugat del vallesPresencialCompetitivoPublicado hace 23 díasIndefinido
🇬🇧Inglés requerido
Grifols

Clinical Affairs Data Specialist

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

What your responsibilities will be

  • Support Clinical Affairs Team in Data Management Workflow
    • Collaborate and oversee Data Management Activities of the assigned clinical studies
    • Participate in the design of Case Report Forms (CRFs) and data collection workflows based on clinical trial protocols.
    • Prepare and Validate Specific Scripts for the Data Workflow
    • Design and Validate EDC systems and related databases.
    • Supporting Clinical Affairs Specialist in executing Data Workflow so monitoring can be performed
    • Supporting internal and external stakeholders in training and managing Data Workflow
    • Keep contact with related software providers
  • Support Clinical Affairs Team in Statistical Analysis of Clinical Trials
    • Prepare and design the statistical approach across the assigned clinical studies
    • Execute Statistical Analysis per plan and protocols including validation of functions if applicable
    • Prepare statistical related information for regulatory submissions

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).

  • Bachelor's degree in Biosciences, Biostatistics, Biotechnology, Pharmacy, Biomedical Sciences or a related field. A Master's degree in Biostatistics, Data Science or a similar discipline will be highly valued.
  • You bring 2-3 years of experience in Data Management, Biostatistics or Clinical Data Analysis, ideally within clinical research, diagnostics, pharma or healthcare environments. Experience in Medical Devices is a plus but not mandatory.
  • You have programming knowledge, knowledge in EDC systems and/or database standards. Knowledge of programming languages such as Python, R or SAS is an advantage.
  • You are familiar with regulatory standards, quality environments and clinical standards as well (e.g., GCP) and understand the importance of data integrity and traceability in clinical studies.
  • You have an analytical mindset and strong problem-solving skills, with the ability to work in a structured and detail-oriented manner.
  • You are proactive and flexible. You are motivated by implementing new tools and improving data systems and processes.
  • Advanced level of English, both spoken and written

What we offer

It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.

Information about Grifols is available at grifols.com If you are interested in joining our company and you have what it takes for such an exciting position, then don't hesitate to apply!

We look forward to receiving your application!

Grifols is an equal opportunity employer.

Flexibility for U Program: Hybrid model.

Flexible schedule: Lunes-Jueves 7-10 a 16-19h y Viernes 8-15h (con la misma flexibilidad de entrada).

Benefits package

Contract of Employment: Permanent position

Location: Sant Cugat del Vallès.

www.grifols.com

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Location: SPAIN : España : Sant Cugat del Valles:[[cust_building]]

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